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First R-Based Submission to FDA: Novo Nordisk set a standard in regulatory submissions to the #FDA. The company achieved a milestone by completing the first-ever submission using #R, a statistical programming language.

The submission covers SDTM and ADaM datasets, detailed programs, documentation, analyses, and TLFs – all crafted using R.

Dive into our blog post by Ismael Rodriguez for insights into the submission process and its #businessimpact. Full details here: go.appsilon.com/first-rbased-s

appsilon.comLearnings from the First R-Based Submission to FDA by Novo Nordisk - R programmingExplore Novo Nordisk's pioneering R-based submission to the FDA, highlighting strategies and key insights in pharmaceutical compliance.